Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
Beth Israel Deaconess Medical Center
32 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary outcomes will include peak flow measurement and symptom reporting before and after the exercise testing. The study will focus on the use of continuous positive airway pressure (CPAP) device. CPAP is FDA-approved for the treatment of various medical conditions, including obstructive sleep apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study subject will be monitored for up to 3 months.
Eligibility
Inclusion Criteria5
- Patient with a diagnosis of ECAC either via bronchoscopy or CT Scan
- Age > 18 years
- Patients that will undergo a diagnostic or therapeutic bronchoscopy as part of their standard of care
- Patients with a baseline 6 MWT
- Patients that have never used CPAP devices in the past
Exclusion Criteria9
- Patients with poorly-controlled respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
- No evidence for acute respiratory tract infection, or respiratory tract infection within the prior 3 weeks
- Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
- Dysrhythmia that might pose a risk during exercise or training
- Any disease or condition that interferes with completion of initial or follow-up assessments
- Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- Subject has an inability to walk >140m (150 yd) in 6 minutes
- Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
- Subject has a known sensitivity to drugs required to perform bronchoscopy.
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Interventions
Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle
An enlarged air leak incorporated into the exhalation valve will be positioned between the mask and the CPAP tubing, allowing airflow resistance of the exhalation port to be almost eliminated by increasing its area, thereby virtually cancelling positive pressure. Also an orifice restrictor in the CPAP circuit will be connected between the CPAP unit and the tubing in order to load the blower with the same airflow resistance as in true CPAP.
Locations(1)
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NCT04217603